FDA Inspection 801691 — Biomat USA, Inc.
The FDA completed an inspection of Biomat USA, Inc. on October 2, 2012 in Indianapolis, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 2, 2012
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Indianapolis, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |
| 333 | 21 CFR 640.64(e) | Prevention of contamination |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9243 | 21 CFR 630.40(a) | Notification |